Patient interface systems

ABSTRACT

A patient interface system includes a nasal seal of flexible material to communicate with at least one airway of the patient, and a primary headgear from which the nasal seal is suspended, said primary headgear having at least one aperture though which at least a portion of the nasal seal is inserted with the primary headgear wrapping about at least one portion of the nasal seal in a sling-like fashion.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/457,272, filed Feb. 16, 2011, and incorporates by reference theentire contents of U.S. Provisional Application No. 61/457,272, filedFeb. 16, 2011 and U.S. Published Patent Application No. 2010/0000534,published on Jan. 7, 2010.

FIELD OF THE TECHNOLOGY

The present technology relates to patient interface systems for deliveryof a flow of breathable gas to a patient. The present technology alsorelates to patient interface systems that may include adhesive(s) tosupport the patient interface in engagement with the patient and/or apatient interface positioning and/or support structure.

BACKGROUND OF THE INVENTION

The use of positive airway pressure (PAP) for the treatment of sleepdisordered breathing (SDB), such as obstructive sleep apnea (OSA), wasdisclosed in U.S. Pat. No. 4,944,310. Treatment using PAP, which may becontinuous PAP (CPAP), involves the use of a patient interface which isattached to the patient's face for the provision of the flow ofbreathable gas. PAP treatment involving the use of a patient interfacethat is sealingly attached to the wearer's face may be referred to asclosed PAP.

For patients that require treatment of OSA, a patient interface, e.g. amask, that forms a seal with the patient's airways may be required.However, the patient may find adapting to current interfaces difficult.For example, the patient may have difficulty sleeping in a familiar,comfortable position once the mask, including the headgear and airdelivery hose, are fitted to the patient to provide the required seal.Although the mask is capable of providing a seal and the prescribedpressure, the patient may be reluctant to use the mask due to theproblem of sleeping comfortably while wearing the mask. The patient mayalso find the mask assembly too obtrusive. These factors may result inthe patient abandoning the treatment.

SUMMARY OF THE TECHNOLOGY

One example of the present technology relates to the use of a siliconenasal or nares seal assembly and a relatively small headgear that maywork in conjunction with an adhesive pad. The small headgear may bepositioned, for example, between the nasal or nares seal and a gusset orconnecting region of the nasal or nares seal assembly. The headgear maybe attachable to the adhesive pad, e.g., by an attachment mechanism suchas hook and loop material. The nasal or nares seal may be in the form ofnasal prongs or nozzles, or it may be a nasal or nares seal that sealsaround both nares in the small region between or in the vicinity of theupper lip and the tip of the user's nose.

Another example of the present technology relates to a patient interfacesystem comprising a nasal seal of flexible material to communicate withat least one airway of the patient; and a primary headgear from whichthe nasal seal is suspended, said primary headgear including a fabricand/or textile material having at least one aperture though which atleast a portion of the nasal seal is inserted with the primary headgearwrapping about at least one portion of the nasal seal in a sling-likefashion. The headgear may work in conjunction with a securing pad thatis secured to the patient's face, e.g., an adhesive pad that isadhesively secured to the nasal bridge region of the patient's face.

Another example of the present technology relates to a patient interfacesystem comprising a nasal seal of flexible material to communicate withat least one airway of the patient, and a primary headgear to which thenasal seal is attached, said primary headgear including a fabric and/ortextile material connected to at least a portion of the nasal seal, withthe primary headgear removably attachable to an adhesive strippositioned on the patient.

Another example of the present technology relates to a patient interfacesystem comprising a nasal seal of flexible material to communicate withat least one airway of the patient; and a primary headgear in which thenasal seal and primary headgear are positively located, inter-engaged,interlocked, intermeshed, sandwiched, and/or abutted against, etc., oneanother. For example, a portion of the nasal seal may extend through anaperture or slot, etc., in the primary headgear, and/or vice versa.

Another example of the present technology relates to a patient interfaceincluding an unobtrusive or low profile nasal seal (e.g., nozzles or anares seal) that may be securely suspended from a relatively smallheadgear. The headgear and nasal seal are structured to inter-engage,etc. with one another, without requiring one or more separate clips toconnect the headgear to the patient interface.

Another example of the present technology relates to a patient interfacethat can be suspended on a patient's face without any “hard” parts, suchas a polycarbonate frame or “shell” to which many typical cushions areconnected, and/or so-called headgear clips which allow connectionbetween headgear straps and the frame/shell. For example, the patientinterface may include a soft and complaint nasal seal (e.g., nasal only,oro-nasal, nozzles, prongs, nares seal, etc.), and a headgear made ofsoft and flexible material, e.g., composite materials such as laminatedfoam and fabric, a non woven fabric, a mesh, etc. The headgear may besuspended from a securing pad that can be adhesively or otherwisesupported on the patient's face (e.g., nasal bridge).

Other aspects, features, and advantages of this technology will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the varioussample embodiments, wherein:

FIG. 1 is a perspective view of a patient interface system according toan example of the present technology in an operational position on amodel patient's head;

FIG. 2 is a front view thereof;

FIG. 3 is a side view thereof;

FIG. 4 is an exploded view of the patient interface system shown inFIGS. 1-3;

FIG. 5 is a top view of a nasal seal and primary headgear subassemblythereof;

FIG. 6 is an exploded view of the nasal seal and primary headgearsubassembly shown in FIG. 5 (with a variant of the primary headgear);

FIG. 7 is a top perspective view of an optional secondary headgear for apatient interface according to an example of the present technology;

FIG. 8 is a side view of a variant of the patent interface system ofFIG. 1 and the secondary headgear of FIG. 7 in an operational positionon a model patient's head;

FIG. 9 is a side view of a variant of the patent interface system ofFIG. 1 and the secondary headgear of FIG. 7 in an operational positionon a model patient's head;

FIGS. 10-21 are top views showing a plurality of small primary headgearsaccording to examples of the present technology;

FIG. 22 is a front view of a patient interface system according to anexample of the present technology in an operative position on a modelpatient's head in use;

FIG. 23 is a top perspective view of the nasal seal and primary headgearsubassembly shown in FIG. 22;

FIG. 24 is rear perspective view thereof; and

FIG. 25 is top view thereof.

DETAILED DESCRIPTION

The following description is provided in relation to several exampleswhich may share common characteristics and features. It is to beunderstood that one or more features of any one example may becombinable with one or more features of the other examples. In addition,any single feature or combination of features in any of the examples mayconstitute an additional feature or features that may be independentlyclaimed and pursued.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. It is also acknowledged that the blowersdescribed herein may be designed to pump fluids other than air.

As used herein, the term “patient interface system” refers to astructure configured to engage the face of a patient and deliver theflow of breathable gas to the patient's airways.

Examples of the present technology relate to the use of an existing orslightly modified silicone nasal or nares seal and a small headgear thatmay work in conjunction with a securing or adhesive pad. The smallheadgear may be positioned, for example, between a nasal or nares sealand a gusset, base or connecting region of the nasal or nares sealassembly. The headgear may be attachable to the adhesive pad, e.g., byan attachment mechanism such as hook and loop material, or adhesive. Thenasal or nares seal may be in the form of nasal prongs or nozzles, or itmay be a nasal or nares seal that seals around both nares in the smallregion between or in the vicinity of the upper lip and the tip of theuser's nose, a shown, for example, in PCT/AU2010/000684 filed Jun. 2,2010, incorporated by reference in its entirety.

FIGS. 1-3 show a patient interface system 5 according to an example ofthe present technology. Patient interface system 5 includes a nasal seal10 of flexible material, e.g., silicone or another elastomer, tocommunicate with at least one airway of the patient. A primary headgear15 is provided from which the nasal seal 10 is suspended. The assemblyor sub-combination of the nasal seal 10 and the primary headgear 15 maybe suspended from the patient's head (e.g., nose), using a securing pad,e.g., an adhesive pad 20.

The patient interface system 5 may include a short tube 25 having afirst end 30 to connect with the nasal seal 10, and a second end 31 toconnect with an air delivery tube via a swivel 32. The first end 30 ofthe short tube may include a gusset or decoupling joint 35 (FIG. 4) toaccommodate for tube drag and rotational forces. The patient interfacesystem may include a vent 40, e.g., a plurality of holes 45, to allowfor CO₂ gas washout.

The primary headgear 15 includes a fabric and/or textile material orlayer having at least one aperture 50 (FIG. 6) though which at least aportion 55 of the nasal seal 10 is inserted, with the primary headgear15 wrapping about at least one portion (e.g., the nozzles) of the nasalseal in a sling-like fashion. The primary headgear 15 includes a centersection 60 having the at least one aperture 50 through which the nozzleheads 150 of the nasal seal extend such that the nasal seal ispositively located against a rim 65 surrounding the aperture 50. The atleast one aperture 50 may include a reinforcement at least partiallyabout the rim, e.g., stitching or a donut/torus shaped reinforcement, toprevent tearing/deformation.

The headgear 15 may be made from a laminate including multiple layers,e.g., a fabric and/or textile or textile and flexible polymeric materialsuch as silicone; a soft, breathable and flexible patient contacting orfacing inner layer such as fabric and/or textile, a soft and flexibleouter layer and a foam-type layer between the inner and outer layers.The headgear may be reinforced with a stiffening material (e.g., plasticor nylon) to add rigidity in one or more regions. The primary headgear15 is made of a soft and flexible material, such as that sold under thetrade name “Breath-O-Prene”.

In an alternative form, primary headgear 15 may be constructed from orconstructed in part from a deformable plastic such as silicone,thermoplastic elastomer, etc. The deformable plastic may be able tochange shape e.g. from a flat position to an in use curved position, becomfortable on the user's face, and receive nozzle heads 150. In afurther example, the first attachment region 80 may be, for example,hook portions that are integrally molded with primary headgear 15. Firstattachment region 80 may be formed of the same material as primaryheadgear 15 or a different material than primary headgear 15. In afurther example, primary headgear 15 may include a stiffer material insome portions for reinforcing, e.g. rims 65 may be lined with asubstantially stiffer material than other regions of primary headgear15. Such an arrangement may ensure structure integrity and preventtearing or wear of the primary headgear in these stiffened regions. Itmay also aid in aligning and fitting primary headgear 15 to nozzle heads150, and supporting nozzle heads 150 in position.

The primary headgear includes at least one arm 70 extending from thecenter section 60. Each arm 70 may extend away from the center section60 linearly, or in a curved or curled fashion, and/or at an angle β(e.g., about 20°-140° from horizontal) relative to the center section asshown in the variants in FIGS. 10-21. This arrangement may enable arms70 to be positioned on the flares or sides of the patient's nose in use,rather than positioning on the patient's cheeks or top lip.Alternatively, or in addition, each arm 70 may include a connection 75provided between the center section 60 and the arm 70 (see for exampleFIGS. 12 and 15). Connection 75 may be a portion of fabric or othermaterial that forms a bridge between the center section 60 and the arm70. Connection 75 may include, for example, supplemental attachments forreceiving a supplemental headgear. For example, connection 75 mayinclude an eye and a supplemental headgear may include a hook, the eyeadapted to receive the hook. Alternative removably attachable mechanismsmay be possible, for example hook and loop, buttons, etc.

The primary headgear may include two or more arms 70 extending from thecenter section 60, e.g., a pair of laterally extending arms as shown inFIGS. 6 and 10-25. Each arm may include a first attachment region 80provided at or near an end of each arm. Each first attachment region 80may include a hook or loop type fastener, for attachment to a secondattachment region, e.g., loop or a hook type fastener 85, provided onthe securing or adhesive pad 20 provided to the patient's face. Thesecuring pad may be supported on the patient's head with one or morestraps.

The securing pad 20 may be in the form of an adhesive pad that has afirst side 90 provided with an adhesive to adhesively contact thepatient's face (e.g., nasal bridge region) and a second side 95 toengage or receive a portion (e.g., the arm(s)) of the primary headgear.The second side 95 may include a second attachment region to engage withthe first attachment region 80. The first and second attachment regionsmay be secured to one another via a hook and loop fastening system.However, the first and second attachment regions may be secured to oneanother via alternative means, for example adhesive, hook and eye clasp.

Alternatively, each first attachment region 80 may include an adhesiveto adhere directly to the patient's face in use, in which case theadhesive pad 20 may not be required. In addition, the first attachmentregion 80 may be in the form of a clip that is received within areceiving portion of the pad 20.

At least an upper or front portion 100 of a perimeter of the centersection 60 is formed to follow the general shape of the apertures 50, soas to form a gap 105 between the apertures. The at least one arm 70 maybe angled or oriented towards the front or upper portion 100. In theexample of FIG. 6, the at least one arm is curved or curled in towardsan upper portion of the center section.

A lower portion 110 of a perimeter is cut out or arc shaped toaccommodate the patient's septum or top lip. Preferably, lower portion110 may avoid or substantially avoid positioning between the mask andthe patient's top lip. This arrangement may permit the mask to rest onthe patient's top lip, and therefore align with the patient's nares.Alternatively, this arrangement may prevent the mask from tiltingtowards the patient's nose tip and away from the top lip or shifting themask in the superior direction of the patient's nose, as the lowerportion may contacting the patient's top lip and then the mask therebyoffsetting the position of the mask. In general the lower or rearportion may be said to have a generally concave shape, e.g., FIGS. 10-18and 20-22. Lower portion may have any other shape adapted to avoid thepatient's top lip, for example the lower portion may comprise a slit orperforation.

An upper portion of the center section may include a raised flap 115(FIGS. 1-4 and 17-19) to cover the patient's nares and/or portion ofnasal seal in use, and/or to support the nasal seal. Raised flap 115 maybe substantially curved or wrapped around the patient's nose tip. Thismay be achieved by flexing the material around the patient's nose tip.Alternatively, raised flap may comprise a dart and stitched portion, thedart and stitching adapted to provide the raised flap with a threedimensional curvature.

Nozzles

The primary headgear 115 may include a pair of apertures 50 provided inthe center section 60, and the nasal seal 10 may be in the form of apair of generally hollow nozzles 120, prongs or puffs that extend thoughrespective ones of the pair of apertures 50. The nozzles 120, e.g., thewidest parts 125 have a cross sectional size that is greater than across sectional size of the apertures 50 (in at least one orientation).The apertures 50 may be round or the apertures may be oval and havemajor axes that converge towards one another at an angle X of about15°-45°, e.g., 30°, in a direction oriented towards the front side 100of the primary headgear (FIG. 6).

The nasal pillows may be as disclosed, for example, U.S. PatentApplication Publications 2007/0144525 A1 and 2006/0283461 A1, andInternational Application PCT/AU2008/001557, filed Oct. 22, 2008, theentire contents of each being incorporated herein by reference. Itshould also be appreciated that the nasal pillows may be as describedin, for example, U.S. Pat. No. 7,318,437, the entire contents of whichare incorporated herein by reference. It should further be appreciatedthat in addition to nasal pillows, the patient interface structure mayinclude nasal pillows or prongs as disclosed, for example, in U.S. Pat.No. 4,782,832 (Trimble), U.S. Pat. No. 7,201,169 (Wilkie et al.), U.S.Pat. No. 7,059,328 (Wood), and WO 2000/074758 (Lovell). It should alsobe appreciated that the cannula(e) and/or nasal pillows or prongs mayinclude features configured to diffuse the flow of air so that noise maybe reduced. Such features are disclosed in, for example U.S. PatentApplication Publication 2009/0044808 A1, and WO 2008/014543 A1, theentire contents of each being incorporated herein by reference.Alternative geometries may be possible.

The hollow nozzles 120 are made of a resilient material that may bedeformable between a normal position and a compressed position. Toassemble the nozzles and the primary headgear, the hollow nozzles aresqueezed to resiliently compress them such that the nozzles 120 can befit into and through the apertures 50, and the nozzles are structured toresiliently expand and return to the normal position once insertedthrough the apertures and released, so as to interlock the primaryheadgear with the nozzles.

Thus, the primary headgear, from which the nasal seal is suspended,provides at least one aperture though which at least a portion of thenasal seal is inserted with the primary headgear wrapping about at leastone portion of the nasal seal in a sling-like fashion (FIG. 1). Thepatient interface includes an unobtrusive or low profile nasal seal thatmay be securely suspended from a relatively small headgear 15. Theheadgear and nasal seal are structured to inter-engage and/or interlacewith one another, without requiring one or more separate clips toconnect the headgear to the patient interface, and without requiring aframe or “shell” to which the cushion and clips are sometimes provided.

The nozzles 120 may be provided to or mounted on a common base or gussetportion 130. The nozzles 120 may be formed in one piece with the base orgusset, or they may be attachable and detachable from the base orgusset.

The center section 60 of the headgear 15 is provided or sandwichedbetween the nozzles 120 and the base or gusset portion.

Each nozzle includes a stalk 140 provided to the base or gusset portionand a generally cone shaped head 150 provided to a distal end of thestalk, the cone shaped head 150 extending through the respectiveaperture. Each cone shaped head includes a base surface 155 oriented toface the base or gusset portion 130, each base surface 155 beingstructured to engage the respective rim 65 (FIG. 6) in an assembled andsuspended condition. The arms 70 are adjusted relative to the pad 20 tomaintain the nasal seal in close proximity contact with the patient'snares, while also maintaining contact between the base surface 155 andrims 65.

Secondary Headgear

It may be desirable to provide fastening arrangements in addition to theprimary headgear 15 and/or adhesive or adhesive pad 20 for positioningand stabilizing the patient interface structure in engagement with thepatient's face. The use of additional fastening arrangements, ormaterials, permit the position of the patient interface structure and/orthe position of the fastening arrangement to be adjusted to provide acomfortable fit while providing efficient therapy via the flow ofbreathable gas. The secondary headgear may assist in counteracting tubedrag forces and thereby stabilize the seal in position on the patient'sface.

For example, while the patient interface system of FIGS. 1-3 may besecured to the patient's face using the primary headgear 15 (optionallyin conjunction with the adhesive pad 20), the system may include furtherstructure to better ensure that the nasal seal remain in sealing contactwith the patient's airways. For example, the patient interface mayinclude a secondary headgear 175 (FIG. 7). As shown in FIGS. 8-9, thesecondary headgear 175 may extend around the back of the patient's headand/or underneath the patient's ears. For example, the secondaryheadgear 175 is dimensioned and configured to extend below the ears ofthe patient in use.

The secondary headgear 175 may be connected to or interact with theremainder of the system in a number of different manners.

As best shown in FIG. 7, the secondary headgear 175 includes twoadjustable length portions 190 connected by a buckle 195. Each lengthadjustable portion includes a hook portion 200 and a loop portion 205.One or more adjustable length portions are also possible.

In an alternative shown in FIG. 8, the secondary headgear 175 may beconnected to laterally spaced portions of the primary headgear 15, e.g.,by placing hooks 180 on the primary headgear.

For example, as shown in FIG. 9, the secondary headgear 175 is connectedto lateral side portions or connectors of the nasal seal. Suchconnectors may be like those described in relation to WO 2009/052560,published Apr. 30, 2009, incorporated herein by reference in itsentirety. In an alternative, the secondary headgear may have one endthat is integral with or in one piece with the nasal seal, and anotherend that can be connected and disconnected relative to the nasal seal.

The primary and secondary headgears 15, 175 may be separate, integrallyformed and/or connectable with one another, or they may be formed in onepiece with one another.

Nares Seal to Encompass Both Nasal Openings/Nares

The nasal seal may be in the form of a nares seal portion tosubstantially surround both nasal openings of the patient. The nasalseal may include a stub that extends through the at least one apertureof the primary headgear such that a junction region formed between theseal portion and the stub engages the rim.

FIGS. 22-25 show another example of the present technology, which alsoincludes a patient interface system including a nasal seal 10 and aprimary headgear 15 that is suspended from the patient's face by anadhesive pad 20 adhered to the nasal bridge region of the patient'sface. However, the nasal seal 10 is in the form of a nares seal thatseals around both nares in the small region between or in the vicinityof the upper lip and the tip of the user's nose, as described inrelation to PCT/AU2010/00684, incorporated herein by reference in itsentirety.

Nasal seal includes a face contacting side 220. FIG. 23-25 show thenasal seal and primary headgear in various orientations, to clearly showa nares portion 225 of the seal that engages with the nares and an upperlip portion 230 that engages with the upper lip. Nasal seal alsoincludes an opposite side that includes a stub 240 for connection to anelbow 250 or air delivery tube 255 that delivers gas at pressures of upto 2-40 cm H₂O, e.g., appropriate for treatment of respiratory or sleeprelated illness.

The primary headgear 15 may include a center section that includes onlya single aperture 50 (FIGS. 15 and 22) though which the stub 240extends. The aperture may be oval or approximately oval and extends in awidth-wise direction of the center section. As shown in FIG. 15, a frontperimeter portion 100 of the center section 60 may be shaped to matchthe oval shaped aperture. A rear perimeter portion 110 of the centersection 60 is concave adjacent the aperture (to accommodate theseptum/upper lip).

While the technology has been described in connection with what arepresently considered to be the most practical and preferred examples, itis to be understood that the technology is not to be limited to thedisclosed examples, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the technology. Furthermore, each individual component of anygiven assembly, one or more portions of an individual component of anygiven assembly, and various combinations of components from one or moreembodiments may include one or more ornamental design features. Inaddition, while the technology has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, COPD,morbid obesity, stroke, barriatric surgery, etc.) can derive benefitfrom the above teachings. Moreover, the above teachings haveapplicability with patients and non-patients alike in non-medicalapplications.

1. A patient interface system comprising: a nasal seal of flexiblematerial to communicate with at least one airway of the patient; and aprimary headgear to which the nasal seal is removably attached, saidprimary headgear including a fabric and/or textile material connected toat least a portion of the nasal seal, with the primary headgearremovably attachable to an adhesive strip positioned on the patient. 2.A patient interface system comprising: a nasal seal of flexible materialto communicate with at least one airway of the patient; and a primaryheadgear including a section having at least one aperture through whichat least a portion of the nasal seal extends, wherein the nasal seal ispositively located against a rim surrounding the aperture.
 3. Thepatient interface system of claim 1, wherein the primary headgear isflexible.
 4. The patient interface system of claim 2, wherein theprimary headgear includes a fabric and/or textile.
 5. The patientinterface system of claim 1, wherein the primary headgear includes alaminate.
 6. The patient interface system of claim 5, wherein thelaminate includes a soft first inner layer to face the patient and asecond outer layer opposite to the first inner layer.
 7. The patientinterface system of claim 1, wherein the primary headgear includes areinforcing layer to add rigidity to the primary headgear.
 8. Thepatient interface system of claim 2, further comprising a secondaryheadgear to extend around the back of the patient's head.
 9. The patientinterface system of claim 8, wherein the secondary headgear is adaptedto extend below the ears of the patient in use.
 10. The patientinterface system of claim 8, wherein the secondary headgear is connectedto one or more lateral side portions and/or connectors of the nasalseal.
 11. The patient interface system of claim 10, wherein at least oneend of the secondary headgear includes a hook to be secured with acorresponding structure on the nare seal.
 12. The patient interfacesystem of claim 8, wherein the secondary headgear is connected tolateral side portions of the primary headgear. 13.-15. (canceled) 16.The patient interface system of claim 1, further comprising a pair ofapertures provided in the center section, and the nare seal comprises apair of generally hollow nozzles that extend through respective ones ofthe pair of apertures.
 17. The patient interface system of claim 16,wherein the nozzles have a cross sectional size that is greater than across sectional size of the apertures in at least one dimension.
 18. Thepatient interface system of claim 16, wherein the nozzles are made of aresilient material that are deformable between a normal position and acompressed position, and to assembly the nozzles and the primaryheadgear, the nozzles are squeezed to resiliently compress the material,wherein the nozzles fit into and through the apertures, and the nozzlesare structured to resiliently expand to the normal position onceinserted through the apertures and released, so as to interlock theprimary headgear with the nozzles. 19.-20. (canceled)
 21. The patientinterface system of claim 16, wherein the nasal seal further comprises abase or gusset portion to which the pair of nozzles are provided, andthe center section of the headgear is provided or sandwiched between thenozzles and the base or gusset portion.
 22. The patient interface systemof claim 21, wherein each said nozzle includes a stalk provided to thebase or gusset portion and a generally cone shaped head provided to adistal end of the stalk, the cone shaped head extending through therespective aperture.
 23. (canceled)
 24. The patient interface system ofclaim 1, wherein the primary headgear includes at least one armextending from the center section.
 25. The patient interface system ofclaims 24, wherein each said arm extends linearly away from the centersection.
 26. The patient interface system of claim 24, wherein each saidarm extends at an angle relative to the center section. 27.-30.(canceled)
 31. The patient interface system of claim 1, wherein a lowerportion of the primary headgear perimeter is cut out or arc shaped toaccommodate the patient's septum or top lip.
 32. The patient interfacesystem of claim 31, wherein the lower portion is concave. 33.-42.(canceled)
 43. The patient interface system of claim 1, furthercomprising an adhesive pad having a first side with an adhesive tocontact the patient's face and a second side to engage a portion of theheadgear.
 44. The patient interface system of claims 43, wherein thesecond side includes a second attachment region to engage with the firstattachment region.
 45. (canceled)
 46. The patient interface system ofclaims 44, wherein the first and second attachment regions are securedto one another via a hook and loop fastening system. 47.-54. (canceled)